(23 days)
Not Found
No
The document describes a kit of mechanical accessories for PTCA procedures and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device components are described as accessories for PTCA procedures, and their functions (balloon inflation, wire control, hemostasis, guidewire manipulation) support other therapeutic devices rather than providing therapy themselves.
No.
The device is used to assist in PTCA procedures by providing tools for balloon inflation and wire control; it does not diagnose a condition.
No
The device description explicitly states it is a "kit of sterile disposable devices" and lists physical components like an inflation device, Y-adaptor, torque device, and insertion tool. These are hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are "accessories for percutaneous coronary angiography (PTCA) procedures." These procedures involve direct intervention within the body (in vivo), not testing samples outside the body (in vitro).
- Device Description: The description reinforces that the devices are "accessories and percutaneous coronary angiography (PTCA) procedures."
- Functionality: The descriptions of the individual devices (inflation device, Y-adaptor, torque device, insertion tool) all relate to manipulating balloons, wires, and other devices within the patient's body during a procedure. They do not involve analyzing biological samples.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such functions.
N/A
Intended Use / Indications for Use
The Encore™ 26 Advantage Kits are intended for use as accessories for percutaneous coronary angiography (PTCA) procedures. They create and monitor balloon inflation and facilitate wire introduction and control.
Individual Device Intended Use:
Encore™ 26 Inflation Device: used with balloon ● dilatation catheters to create and monitor pressure in the balloon, and to deflate the balloon.
Gateway™ Plus Y-Adaptor: used for providing hemostasis around guidewires, balloon dilatation catheters, and other therapeutic devices.
Torque Device: used for guidewire manipulation.
Insertion Tool: used to facilitate the introduction of a guidewire.
The EncoreTM 26 Inflation devices are recommended for use with balloon dilatation catheters to create and monitor pressure in the balloon, and to deflate the balloon. The GateWayTM PLUS Y-Adapter is recommended for providing homeostasis around balloon dilatation catheters, guidewires, and other therapeutic devices during general intravascular procedures. The Torque Device is used for guidewire manipulation during general intravascular procedures. The Insertion Tool is used to facilitate the introduction of a guidewire during general intravascular procedures.
Product codes (comma separated list FDA assigned to the subject device)
MAV
Device Description
The Encore™ 26 Advantage Kit is a Kit of sterile disposable devices intended for use as accessories and percutaneous coronary angiography (PTCA) procedures. They allow for balloon inflation and wire control.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design Verification and Design Validation Testing was performed to verify that the performance and usability of the modified Insertion Tool remains substantially equivalent to the predicate device via K140673. In addition Sterilization, Packaging and Biocompatibility testing verifies the overall substantial equivalence to the kit predicate. No additional testing was required for kit inclusion. No new safety or performance issues were raised during the device testing. Therefore, these devices may be considered substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Special 510(k) Submission
i
APR 1 7 2014
510(k) Summary
per 21 CFR §807.92
| Submitter's Address
Contact Name and
Information | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311
Lisa Mee
Senior Regulatory Affairs Specialist
Phone: 763-494-1185
Fax:
763-494-2222
e-mail: lisa.mee@bsci.com | | |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| | | | |
| Date Prepared | 24 Mar 2014 | | |
| Proprietary Name | Encore™ 26 Advantage Kit | | |
| Common Name | Balloon Inflation Kit
Comon name of the Kit components:
Inflation device, Insertion Tool, Y-Adaptor and Torque Device | | |
| Product Code | MAV - Syringe, Balloon Inflation | | |
| Classification | Class II, 21 CFR Part 870.1650 - Cardiovascular | | |
| Predicate Device(s) | Encore™ 26 Advantage Kit
K123214
Nov 13, 2012 | | |
| | SCIMED AVENUE Coronary
K922410
Jul 23, 1992 | | |
| | Guidewire Insertion Tool | | |
| Device Description | The Encore™ 26 Advantage Kit is a Kit of sterile disposable
devices intended for use as accessories and percutaneous
coronary angiography (PTCA) procedures. They allow for
balloon inflation and wire control. | | |
| Intended Use | The Encore™ 26 Advantage Kits are intended for use as
accessories for percutaneous coronary angiography (PTCA)
procedures. They create and monitor balloon inflation and
facilitate wire introduction and control.
Individual Device Intended Use:
Encore™ 26 Inflation Device: used with balloon
●
dilatation catheters to create and monitor pressure in the
balloon, and to deflate the balloon.
Gateway™ Plus Y-Adaptor: used for providing
hemostasis around guidewires, balloon dilatation
catheters, and other therapeutic devices.
Torque Device: used for guidewire manipulation.
Insertion Tool: used to facilitate the introduction of a
guidewire. | | |
| | | | |
1
| Indications for Use | Individual Device Indications for Use: |
|---|---|
| Comparison of | |
| Technological | |
| Characteristics | The Encore™ 26 Inflation devices are recommended for |
| use with balloon dilatation catheters to create and | |
| monitor pressure in the balloon, and to deflate the | |
| balloon. The GateWay™ PLUS Y-Adapter is recommended for | |
| providing homeostasis around balloon dilatation | |
| catheters, guidewires, and other therapeutic devices | |
| during general intravascular procedures. The Torque Device is used for guidewire manipulation | |
| during general intravascular procedures. The Insertion Tool is used to facilitate the introduction of | |
| a guidewire during general intravascular procedures. | |
| The proposed Encore™ 26 Advantage Kit Inflation device, Y- | |
| Adaptor and Torque device components incorporate | |
| substantially equivalent design, fundamental technology, | |
| manufacturing processes, packaging, sterilization and intended | |
| use as the Inflation device, Y-Adaptor and Torque device | |
| components featured in the Boston Scientific predicate Encore™ | |
| 26 Advantage Kit (K123214). |
The proposed Encore " 26 Advantage Kit Insertion Tool ce component incorporates substantially equivalent design, fundamental technology, manufacturing processes, packaging, sterilization and intended use as the SCIMED AVENUE Coronary Guidewire Insertion Tool device cleared for marketing under K922410.
Comparison to Predicates:
.
| Characteristic | Proposed compared to
Predicates |
|--------------------------|-----------------------------------------------------------------------------------|
| Mechanism of Action | Same mechanism of action. |
| Components | Same components,
configuration, design and
function. |
| Materials | Modified Insertion Tool has
equivalent materials (sheath
and hub colorant). |
| Packaging | Same packaging materials and
packaging configuration. |
| Sterilization Method/SAL | Same method and level of
sterility assurance. |
| Device Compatibility | Same compatibility. |
| Device Dimensions | Modified Insertion Tool has
equivalent dimensions. |
| Biocompatibility | Same biocompatibility. |
2
Encore™ 26 Advantage Kit
Special 510(k) Submission
Performance Data
Design Verification and Design Validation Testing was performed to verify that the performance and usability of the modified Insertion Tool remains substantially equivalent to the predicate device via K140673. In addition Sterilization, Packaging and Biocompatibility testing verifies the overall substantial equivalence to the kit predicate. No additional testing was required for kit inclusion.
No new safety or performance issues were raised during the device testing. Therefore, these devices may be considered substantially equivalent to the predicate device.
Conclusion
Based on the indications for use, technological characteristics, safety and performance testing, the proposed Encore™ 26 Advantage Kit has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Encore™ 26 Advantage Kit as submitted in K123214 and the SCIMED AVENUE Coronary Guidewire Insertion Tool as submitted in K922410.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Public Health Scrvice
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 17, 2014
Boston Scientific Corporation c/o Lisa Mee Senior Regulatory Affairs Specialist One Scimed Place Maple Grove, MN 55311
Re: K140745
Trade/Device Name: Encore™ 26 Advantage Kit Regulation Number: 21 CFR 870.1650 Regulation Name: Balloon Inflation Kit Regulatory Class: II Product Code: MAV Dated: March 24. 2014 Received: March 25, 2014
Dear Ms. Mee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be
4
Page 2 - Ms. Lisa Mee
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number (if known): K140745
Device Name: Encore™ 26 Advantage Kit
Indications for Use:
The Encore 26 Advantage Kit is a kit of sterile disposable devices intended of ruse as accessories for percutaneous coronary angiography (PTCA) procedures. They allow for balloon inflation and wire control.
- Encore™ 26 Inflation Device: indicated for use with balloon dilatation . catheters to create and monitor pressure in the balloon, and to deflate the balloon.
- Gateway™ Plus Y-Adaptor: used for providing hemostasis around balloon . dilatation catheters, guidewires and other therapeutic devices during general intravascular procedures.
- Torque Device: used for guidewire manipulation during general ◆ intravascular procedures.
- Insertion Tool: used to facilitate the introduction of a quidewire during . general intravascular procedures.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR .
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bram D. Zuckerman -S 2014.04.17 17:31:34 -04'00'
Boston Scientific Corporation
. Attachment 1